ATYR1923 Well-Tolerated at all Doses Tested, with No Significant Adverse Events
Pharmacokinetic Profile Supports Potential Once-Monthly Dosing
SAN DIEGO, June 26, 2018 (GLOBE NEWSWIRE) -- aTyr Pharma, Inc. (Nasdaq:LIFE), a biotherapeutics company engaged in the discovery and development of innovative medicines based on novel immunological pathways, today announced positive data from its Phase 1 clinical trial of ATYR1923, an immuno-modulatory therapeutic candidate with potentially broad therapeutic application in the treatment of interstitial lung diseases.
This first-in-human, randomized, double-blind, placebo-controlled study was designed to investigate the safety, tolerability, immunogenicity and pharmacokinetics of intravenous ATYR1923 in healthy volunteers. The Phase 1 study enrolled 36 healthy volunteers who were randomized to one of six cohorts and received a single infusion of intravenous ATYR1923 or placebo. Doses of ATYR1923 ranged from 0.03 mg/kg up to 5.0 mg/kg. The results indicate that the drug was generally well-tolerated at all dose levels tested, with no significant adverse events or induction of anti-drug antibodies observed following ATYR1923 dosing or throughout the one-month follow-up period.
The pharmacokinetics (PK) of ATYR1923 following single-dose administration were linear across the evaluated dose range. Higher ATYR1923 doses yielded sustained serum concentrations through the end of the one-month follow-up period that were above the predicted therapeutic threshold, supporting the potential for a once-monthly dosing regimen.
“We are encouraged by our Phase 1 safety and tolerability data, which support the continued clinical development of ATYR1923 for patients with inflammatory interstitial lung disease,” said Sanjay Shukla, M.D., M.S., President and CEO of aTyr. “The PK profile of ATYR1923 supports once monthly dosing, which we believe would be attractive to our potential patient population. This is an important first step in our clinical program for ATYR1923 and we will be using this data alongside our ATYR1923 translational research activities as we develop and initiate a patient trial in the fourth quarter of this year.”
aTyr is a clinical-stage biotechnology company engaged in the discovery and clinical development of innovative medicines using its knowledge of tRNA synthetase biology. aTyr is focused on the therapeutic translation of the Resokine pathway, comprised of extracellular proteins derived from the histidyl tRNA synthetase (HARS) gene family. aTyr’s clinical stage ATYR1923 candidate augments the Resokine pathway and is designed to temper immune engagement in interstitial lung diseases. aTyr’s immuno-oncology research program targets the Resokine pathway using antibodies to enhance the immune response in tumor settings. aTyr has built an intellectual property estate, to protect its pipeline, comprising over 250 issued patents or allowed patent applications that are owned or exclusively licensed, including over 300 potential protein compositions derived from tRNA synthetase genes. For more information, please visit http://www.atyrpharma.com.
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|Sr. Director, Investor Relations|
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